Harmonized Standards Medical Devices EU-MDR I ColabON

Arlette Schilter
Mar 19, 2024
4 min read

Updated: Mar 23

Accelerate your MDR market access. Current list of harmonized standards for medical devices (30.January 2026). Automate compliance with ColabON now!

Last Updated: March 23, 2026 | Read Time: 4 min.

For many MedTech startups and CEOs, Harmonized Standards for Medical Devices sound like dry bureaucracy. In reality, they are your most powerful lever for liquidity, investor confidence, and market velocity.

Executive Summary for Founders: > Using harmonized standards grants you the "Presumption of Conformity." This means the Notified Body accepts your safety evidence faster, minimizing back-and-forth questions and shortening your time-to-market by up to 12 months.

Current Status of Harmonized Standards (January 2026)

The transition to EU-MDR is a moving target. Many critical standards are still not officially listed in the Official Journal of the EU.

✅ Only 21% of relevant standards are currently harmonized (48 out of 226).
⚠️ 79% of standards remain in a "regulatory grey zone."
#3 Prominent Voids

The CEO Risk: If your engineering team uses the wrong versions, you risk a rejection of your Technical Documentation at the 11th hour—a nightmare for your next funding round.

The List for IVDs is now here to be found.

List of harmonized standards medical devices

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The Standard Harmonization Plans for medical devices and IVDs

Mandate M/575 - C(2021)2406 : 2021-03-12 M/575 Amd 1 – C(2023)694

We have devoted significant effort to ensure the accuracy of this list, although its creation involves meticulous manual work. If you happen to spot any errors, we would greatly appreciate your feedback so that we can make the necessary corrections. We extend our gratitude to SWITEC and SNV for their invaluable expert contributions.

Official Publications of Harmonized Standards Medical Devices to MDR

Status: 17.10.2025

Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council

Prominent Voids in Harmonised Standards Medical Device I Status March 2026

Here are a few important standards from the top of my head that are missing on the list of harmonised standards. These are quite crucial standards that have a direct impact on patient safety. 🩺

Where can I find harmonised standards?

Harmonised standards can be found on official websites such as the European Commission's website, which maintains a list of harmonised standards under various regulations, including the MDR (Medical Device Regulation). Additionally, harmonised standards can be accessed through national standardisation bodies such as DIN in Germany, BSI in the UK, or international bodies like ISO and CEN. These sources offer the most up-to-date versions of harmonised standards relevant to various industries, including medical devices.

MDR harmonised standards (official & current)

IVDR harmonised standards (official & current)

How to identify a harmonised standard?

To identify a harmonised standard, check the official lists provided by the European Commission. A harmonised standard will have a reference number and be linked to specific EU regulations such as the MDR. It is typically prefixed by "EN" followed by the corresponding ISO or IEC number, indicating that it has been harmonised for use within the European Union to ensure compliance with regulatory requirements. Read the scope to understand the applicability... or get in touch with us...

What are harmonized standards for medical devices?

Harmonised standards for medical devices are specific technical standards that have been harmonised under the EU's Medical Device Regulation (MDR). These standards provide manufacturers with a clear framework to demonstrate compliance with safety and performance requirements. Common harmonised standards for medical devices include EN ISO 13485 for quality management systems and EN ISO 14971 for risk management. These standards help ensure that medical devices meet essential regulatory requirements for the EU market.

What is MDR standards?

MDR standards refer to the harmonised standards that support the Medical Device Regulation (MDR) in Europe. These standards cover various aspects such as quality management, risk management, biocompatibility, and clinical evaluation of medical devices. Following MDR standards helps manufacturers ensure that their medical devices comply with EU regulatory requirements, making them eligible for CE marking and placement on the European market.

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Best Practices

Involve your notified body early
Discuss this topic with pears from other companies
Use the harmonised standards whenever available, else use the FDA consensus standards

ColabON: Access to all data at clause level

With ColabON, you gain access to all relevant norms and regulations for the medical device / in vitro diagnostic industry in a structured and easily understandable format. The data is provided at clause level, enabling you to conduct precise and detailed analysis.

Get the current and planned harmonized standard list for medical devices and ivds

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